Cardiac FailureEVACaReNCT07415447
Cardiac Remodelling Following Endovascular Repair of the Aorta
An observational study of Cardiac Failure and Aortic Disease, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 2 sites in Portugal.
Trial summary
To assess the effects of endovascular aortic repair on cardiac morphology and function Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure, Aortic Disease
- What is being tested?
- cardiac magnetic ressonance
- How many people
- 40 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will include consecutive patients, >18 year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms (TAA), penetrating aortic ulcers (PAU) or intramural hematomas (IMH) managed with total endovascular aortic repair in elective setting. We will exclude patients with heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV; LV wall motion abnormality; moderate to severe valve disease, history of (or expected within the study period) cardiac/aortic surgery; coronary artery disease; atrial fibrillation or congenital heart disease. Additionally, we will dismiss patients with connective tissue disorders, chronic kidney disease (eGFR <30 mL/min/173 m2), moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnea Scale (mMRC) 3-4, and standard CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
Who may be able to join
- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.
Who cannot join
- Heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV.
- LV wall motion abnormality.
- Moderate to severe valve disease.
- History of (or expected within the study period) cardiac/aortic surgery.
- Coronary artery disease.
- Atrial fibrillation.
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- Congenital heart disease.
- Connective tissue disorders.
- Chronic kidney disease (eGFR <30 mL/min/173 m2).
- Moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnoea Scale (mMRC) 3-4.
- CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saúde Santa Maria
Lisbon, 1649-028
CIC, +351961948653, CIC@ulssm.min-saude.pt
- Not yet recruiting
Unidade Local de Saúde de Santa Maria, E.P.E.
Lisbon
About this study
To assess the effects of endovascular aortic repair on cardiac morphology and function
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.
The same evaluation will be performed at 6- and 12-months post-surgery.
- Conditions
- Cardiac Failure, Aortic Disease
- Being tested
- cardiac magnetic ressonance
- Keywords
- cardiac, failure, aortic, disease
- Medical subject headings
- Heart Failure, Aortic Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic ressonanceDiagnostic test
In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function
| Study group | Role | What they receive |
|---|---|---|
| Participants submitted to aortic repair | Participants submitted endovascular repair of the aorta Receives: Diagnostic Test: cardiac magnetic ressonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period.
The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR.
Measured: 12-month period
Secondary outcomes (7)
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period.
The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline and 6 months, measured in grams/mililiters/percentage through CMR and ECHO.
Measured: 6-month period
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period.
The cardiac remodelling will be estimated through the variables of left ventricular volume/strain at baseline and 12 months, measured in mililiters/percentage through CMR and ECHO.
Measured: 12-months period
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods.
The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline, 6 months and 12 months, measured in grams/mililiters/percentage through CMR and ECHO.
Measured: 6- and 12-months periods
To correlate heart proximity and endograft extension with cardiac remodelling variables.
The cardiac remodelling will be correlated with the proximity and extension of aortic endografts, measured in milimeters, throught the analysis of the previously described cardiac remodelling variables and the analysis of CT scans.
Measured: 12-month period
To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months
The cardiac biomarker will be obtained thorught blood sample analysis at 6-months and 12-months, comprised by the following:
Soluble suppression of tumorigenicity-2 (sST2). Collagen synthesis biomarkers (PICP, PINP, PIIINCP, PIIINP). Collagen type I degradation biomarker (CITP). B-type natriuretic peptide and terminal of the prohormone brain natriuretic peptide (BNP, NT-proBNP).
High sensitivity C Reactive protein (hsCRP). Galectin 3 (Gal3). Fibroblast activation protein (FAP). Troponins (I and T). Proteinomic and metabolomic parameters
Measured: 6-month and 12-month periods
To compare the agreement between measurements ECHO and CMR measurements.
Measured: 12-month period
To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR.
The patient's blood pressure will be evaluated in clinical visits at 1-month, 6 months and 12 months, mesured em mmHg.
Measured: 1-month, 6-months and 12-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Augusto Ministro, Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415447
- Sponsor's protocol ID
- 2023.15211.PEX
- Other IDs
- 2023
- Acronym
- EVACaRe
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Remodelling Following Endovascular Repair of the Aorta
- ClinicalTrials.gov ID
- NCT07415447
- Acronym / sponsor ID
- EVACaRe / 2023.15211.PEX
- Conditions
- Cardiac Failure, Aortic Disease
- Keywords
- cardiac, failure, aortic, disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lisbon Academic Medical Center - Centro Académico de Medicina de LisboaResearch network
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effects of endovascular aortic repair on cardiac morphology and function
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.
The same evaluation will be performed at 6- and 12-months post-surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants submitted to aortic repair | – | Diagnostic Test: cardiac magnetic ressonanceParticipants submitted endovascular repair of the aorta |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will include consecutive patients, >18 year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms (TAA), penetrating aortic ulcers (PAU) or intramural hematomas (IMH) managed with total endovascular aortic repair in elective setting. We will exclude patients with heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV; LV wall motion abnormality; moderate to severe valve disease, history of (or expected within the study period) cardiac/aortic surgery; coronary artery disease; atrial fibrillation or congenital heart disease. Additionally, we will dismiss patients with connective tissue disorders, chronic kidney disease (eGFR <30 mL/min/173 m2), moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) <50% or Modified Medical Research Council Dyspnea Scale (mMRC) 3-4, and standard CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).
Key inclusion criteria (1 listed)
- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.
Key exclusion criteria (11 listed)
- Heart failure with an ejection fraction <35 vs 50% or New York Heart Association (NYHA) class III and IV.
- LV wall motion abnormality.
- Moderate to severe valve disease.
- History of (or expected within the study period) cardiac/aortic surgery.
- Coronary artery disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac magnetic ressonanceIn patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function | Diagnostic test | Participants submitted to aortic repair |
Primary outcome
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period.
Time frame: 12-month period
The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR.
7 secondary outcomes
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period.
Time frame: 6-month period
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period.
Time frame: 12-months period
To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods.
Time frame: 6- and 12-months periods
To correlate heart proximity and endograft extension with cardiac remodelling variables.
Time frame: 12-month period
To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months
Time frame: 6-month and 12-month periods
To compare the agreement between measurements ECHO and CMR measurements.
Time frame: 12-month period
To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR.
Time frame: 1-month, 6-months and 12-month period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Failure and Aortic Disease, run by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Augusto Ministro Augusto Ministro (00531 210405814, cic@ulssm.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period. (time frame: 12-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.